| Biossays Direct Bilirubin Controls | 06947145545963 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Class C | |
| Biossays Monoamine oxidase Calibrator | 06947145546588 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Class B | |
| careSTART™ Total Bilirubin Biosensor Control | 08809446080964 | WELLS BIO, INC. | Unknown class | |
| Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3) | 05055273217926 | Randox Laboratories Limited | Class B | |
| MAS Bilirubin Liquid Assayed Bilirubin Control | 00884883004610 | Microgenics Corporation | Unknown class | |
| MAS Bilirubin Liquid Assayed Bilirubin Control | 00884883004627 | Microgenics Corporation | Unknown class | |
| MAS Bilirubin Liquid Assayed Bilirubin Control | 00884883004634 | Microgenics Corporation | Unknown class | |
| MAS® Bilirubin Liquid Assayed Bilirubin Control | 00884883003835 | Microgenics Corporation | Unknown class | |
| MAS® Bilirubin Liquid Assayed Bilirubin Control | 00884883003842 | Microgenics Corporation | Unknown class | |
| MAS® Bilirubin Liquid Assayed Bilirubin Control | 00884883003859 | Microgenics Corporation | Unknown class | |
| MAS® Bilirubin Liquid Assayed Bilirubin Control | 00884883003866 | Microgenics Corporation | Unknown class | |
| MAS Bilirubin Max, Level 1 | 00884883009516 | Microgenics Corporation | Class C | |
| MAS Bilirubin Max, Level 2 | 00884883009523 | Microgenics Corporation | Class C | |
| MAS Bilirubin Max, Level 3 | 00884883009530 | Microgenics Corporation | Class C | |
| MAS Bilirubin Max, Sample Pack | 00884883009547 | Microgenics Corporation | Class C | |
| VALIDATE® GC4 Test Set | 00859110005418 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005425 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005432 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005449 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005456 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005463 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005470 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® GC4 Test Set | 00859110005487 | LGC Clinical Diagnostics, Inc. | Unknown class | |